An analysis published Tuesday in JAMA finds that androgen deprivation therapy (ADT) does not appear to raise the risk of death from cardiovascular causes. However, the analysis could not stratify patients by pre-existing cardiovascular disease, which means there may be a small group of men who experience an increased risk of cardiovascular death stemming from use of the drugs.
Last year, the FDA asked manufacturers to add new warnings to the labels of gonadotropin-releasing hormone (GnRH) agonist-based ADT to warn of the potential risk of heart disease and diabetes associated with their use after a review of six studies showed a small increased risk.
The analysis was based on a review of eight randomised clinical trials on such therapies. Over a range of between seven and 13 years of follow-up, 255 cardiovascular deaths occurred among a group of 2200 patients treated with ADT, compared with 252 such deaths in a control group of 1941 patients. For men who took hormones for six months, the overall incidence of cardiovascular death was 10.5 percent, versus 10.3 percent for men not on hormone therapy, and for those who took hormones for three years or more, the incidence of cardiovascular death was the same among men not given the therapy at about 11.5 percent.
Moreover, among men receiving hormone therapy, 443 died from prostate cancer, versus 522 men not receiving hormone therapy. The researchers noted that overall, those in the ADT arm had a 14 percent lower risk of dying from any cause, the researchers found.
Commenting on the data, lead author Paul Nguyen remarked that “for the majority of men with aggressive prostate cancer, [ADT] was associated with better survival and no increased risk of dying from cardiovascular causes.” Noting that “the pendulum may have swung too far away from” use of the drugs following the FDA’s announcement, he said that the study’s findings “should be reassuring for the vast majority of patients considering androgen deprivation therapy.”
In an accompanying editorial, William Kelly noted that “the use of hormone therapy and radiation is of benefit for patients.” However, he noted that for some patients, such as men who will not die from their prostate cancer, the risk of hormone therapy may be greater than the benefit. “You have to understand the risk-benefit ratio in each population. You can’t just apply it across the board to all patients,” Kelly warned.